MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 1 S/A CTB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPB841D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one dispensed suture, one winding former with five detached needles and three needle sutures were received for analysis.The product code vcpb841d is multistrand and contains eight strands per packet.Upon visual inspection of detached needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined under magnification with no suture remnant noted.However, a short insertion was observed in the end of the dispensed suture, as the insertion end of the suture did not meet the requirement.The others four sutures were not returned for evaluation.In the inspections of three needle suture combinations the swage and attachment area were noted to be as expected.As the sutures are absorbable and the duration of exposure of the suture in the environment could not be determined, the functional test could not be performed.Based on the information currently available, short insertion issue was identified as wrong number of strands during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was reported by a sales rep that, after opening the package, it was found that the needle and the suture had been detached.It was a control release needle.Another product was used to complete the case.Upon visual inspection of detached needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined under magnification with no suture remnant noted.However, a short insertion was observed in the end of the dispensed suture, as the insertion end of the suture did not meet the requirement.The others four sutures were not returned for evaluation.In the inspections of three needle suture combinations the swage and attachment area were noted to be as expected.As the sutures are absorbable and the duration of exposure of the suture in the environment could not be determined, the functional test could not be performed.Based on the information currently available, short insertion issue was identified as wrong number of strands during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 8X18IN 1 S/A CTB-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24431569
• Report Number: 2210968-2026-01936
• Device Sequence Number: 10227571
• Product Code: GAM
• UDI-Device Identifier: 10705031056640
• UDI-Public: (01)10705031056640(17)300630(10)109PAQ
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCPB841D
• Device Lot Number: 109PAQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown